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OpenTrials
Completed

NCT Number: NCT00380445

Effect of Vildagliptin on Fat and Muscle Metabolism in Patients With Type 2 Diabetes

Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Investigative Centers, Germany

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be able to complete a 3-week wash-out of current anti-diabetic medication
  • Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
  • Must discontinue beta-blockers and lipid lowering drugs
  • Blood glucose criteria must be met
  • BMI in the range 30-35

Exclusion criteria

  • History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Need for insulin within 3 months or patients on thiazolidinediones
  • Patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study
  • Significant concomitant disease or complications of diabetes
  • Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
  • High tryglycerides as defined by the protocol
  • Smokers who cannot abstain from smoking during the treatment periods

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes

Secondary outcomes

  1. To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Effect of Vildagliptin on Adipose Tissue and Skeletal Muscle Metabolism in Obese Patients With Type 2 Diabetes

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 26, 2006
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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